Singapore legislation
Regulation 12
Regulation 12
Requirements for issue of manufacturer’s licence
For the purposes of section 24(2)(a)(i) of the Act, the requirements that must be satisfied for the issue of a manufacturer’s licence for an active ingredient are that —
the applicant for the licence is able to provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities that are necessary for all of the following:
carrying out the manufacture of the active ingredient to be authorised by the licence;
the proper handling, storage and distribution of the active ingredient so as to prevent the deterioration of the active ingredient while it is in the applicant’s ownership, possession or control;
the applicant for the licence is able to conduct all manufacturing operations in such a way as to ensure that the active ingredient is of the correct identity and conforms with the applicable standards of quality for that active ingredient; and
the applicant for the licence is able to comply with the Good Manufacturing Practice standard in relation to the manufacture of the active ingredient.